Mental Health Clinical Research

MEHRNOOSH HADADI

Address: **** ********** ** *** ***, McLean, VA 22102

Phone: 410-***-****

Email: **********@*****.***

Citizenship: US Citizen

SUMMARY SKILLS

1.Clinical/Research Development (R&D):

a.Clinical Trial: Study design and evaluation, Protocol writing.

b.Regulatory/Drug Development: (IND, NDA, BLA), Drug labeling, new drug safety review, Post marketing drug safety review

2.Clinical research experiences:

a.Cancer

b.Mental Health/ Neuroscience/Psychiatry

c.Non communicable disease (Diabetes and cardiovascular diseases)

d.Communicable diseases (HIV, TB, STDs)

3.Health system activities:

a.Epidemiology and Global Health

b.Public Health

c.Health Policy and international Health Regulation

d.Minorities, refugees, and disparities research

e.Social determinants of health

f.Disaster managements and complex emergencies

g.Monitoring and evaluation

h.Decentralization/ health sector reform

i.Designing guidelines and training manuals

4.General Skills:

a.Leadership/managing health projects.

b.Problem solving

c.Public speaking

d.Teaching and training

e.Communication and negotiation

EXPERIENCE

Food and Drug Administration (FDA) October 2019- October 2023

Department of Health and Human Services

10903 New Hampshire Avenue, Silver Spring, MD 20993

Senior Staff Fellow/ Clinical Reviewer, (GS-13, 40+ hrs/wk,)

Performed scientific reviews and analyses of proposals for studies on oncology indications and new medication for cancer treatment.

Performed regulatory assessment on proposed trials and applications for cancer treatment medication. This includes

oReviewing the Investigational New Drugs INDs for phase 1, phase 2 and phase 3 of clinical trials studies.

oReviewing the New Drug Applications (NDAs), Biologics License Applications (BLAs), Investigational brochures(IB) and drug post marketing evaluation.

Participated in drug labeling and developed/ reviewed clinical section of the label(brochure) of the approved new medication for cancer treatment or new indication of the available medication.

Reviewed safety, efficacy, and reliability of the proposed trials for new investigational cancer medication based on the proposed data by the Sponsor and searched available articles and previous trials to ensure the safety of the study for the participants.

Reviewed the potential unfavorable side effects of the study medication on trial’s participants and evaluated the foreseeable risks of the proposed studies to humans.

Reviewed the proposed measures to manage the foreseeable risks of the new medication and developed essential measures to manage the potential risks and side effects.

Provided input to the sponsors to develop the befitted protocols and study design:

oSelecting the appropriate objectives/endpoints for the study,

oDefining the appropriate dose limiting toxicities (DLTs),

oIdentifying the right target population and eligibility criteria

o Developing study procedures and required safety monitoring measures.

Developed the necessary safety evaluation and procedure to avoid any life threating events for the study participants

Provided guidelines and instruction on developing the patient informed consent form (ICF) to inform patients about the study procedure and potential side effects of the treatment and their rights.

Reviewed clinical study reports (CSRs), Development Safety Update Reports (DSUR), Annual reports and safety study reports for the ongoing trials, submitted by the sponsors.

Participated in training workshops and conferences and meetings with the Sponsors as a clinical focal point.

Amarex Clinical Research, LLC Germantown, MD May 2017- October 2019

20201 Century Blvd, Germantown, MD 20874

Clinical Trial Lead (40+ hrs/wk)

Managed all operational aspects of assigned clinical trials, including study start-up, enrollment, study conduct, close-out and the clinical study report (CSR) process.

Prepared and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters), Including Colorectal cancer, Non-Hodgkin’s Lymphoma, Breast Cancer, GVHD, Solid Tumors, UTI and cutaneous warts.

Served as primary contact for site-facing activities and support for clinical questions regarding the study procedures by the clinical staff within all study sites. Conducted and run activities related to data generation and validation, including case report form (CRF) design, clinical data review/query resolution; ensure consistent, quality data review.

Served as a contact for study regulatory activities and any technical questions by the studies’ Sponsors.

Directed/participated drafting clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).

Worked with CRO to provide information required for development of trial budget, CRO scope of work and interactions, created and implemented corrective action plan when performance modification was required.

Worked with CRO to develop and revised study specific plans and detailed timelines and ensure that transferred obligations and performance expectations are met.

Prepared and presented the organization works and achievement in r various conferences and meeting, including; National Alliance for Mental Health, 2018.

Monitored progress of site activation and conducted monitoring visits and acted on any deviations from plan and developed/implemented patient recruitment and retention strategies.

Ensured data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites.

Served as the main point of contact for clinical operations of the designated projects.

University of New England, College of Graduate and Professional Studies (CGPS)

716 Stevens Ave.

Portland, ME 04103 January 2016 January 2018

Adjunct Faculty

Taught on-line the following courses for 3 semesters

GPH-740 - Global Health

GPH 714 – Principles of Public Health

Responsibilities:

Prepared and delivered lectures to undergraduate or graduate students on epidemiologic studies, clinical trial design and monitoring, global health.

Evaluated and graded students' class work, assignments, papers, and final exam.

Initiated, facilitated, and moderated classroom discussions to engage students’ participation.

Acted as an adviser to the students.

Memosyn Neurology Institute July 2013 November 2016

Lutherville, MD

Clinical Trial Director and Co-investigator

I worked as Co-investigator in a clinical trial study titled.

"Cerebrovascular and Cognitive Improvement by Resveratrol and Fruit-flow-II (CCIRF-II)". Clinical trial Identifier; NCT01766180.

Main responsibilities included of:

Directed the study procedure and patients’ assessment according to the study protocol.

Performed memory assessment, using CANTAB software and other standard tests.

Supervised all aspects of the trial and daily based activities of the study including staffs and client management, providing sufficient logistics and monitor and report on the study status and progress towards deliverables goals.

Managed and supervised data entry and analysis.

Johns Hopkins Bloomberg School of Public Health May 2013 July 2016

Division of International Health, Center for Refugee and Disaster Response

615 N Wolfe St, Baltimore, MD 21205

Post-Doctoral Fellow

Main responsibilities:

Conducted research and policy analysis on health status of Afghan refugees/migrants.

Performed systematic review of articles and collecting and analyzing relevant data on health status of Afghan Refugees and migrants, residing in Iran.

Researched on child labor status in Afghanistan including review of literature and data collection and analysis.

Drafted reports, situation analysis and papers on health status Afghan Refugees and migrants.

Tehran University of Medical Sciences January 2011 April 2013

Center for Endocrine Diseases Research

Researcher

Involved in team activities to perform research, review of articles, design and monitoring of non-communicable disease research.

Johns Hopkins Bloomberg School of Public Health August 2010 December 2010

Division of Mental Health

Post-Doctoral Fellow

Conducted review of litrature on child labor in Afghanistand and amomg the Afghan child refugees/migrants who residing in Iran.

United Nations High Commissioner for Refugees (UNHCR) January 2010 July 2010

Tehran, Iran

Health Officer/ Focal Point, United Nations High Commissioner for Refugees (on Contract per UNHCR payroll)

Developed policy and directing the initiative to achieve a better health condition for the Afghan and Iraqi refugees who resided in Iran, according to UNHCR guidelines.

Evaluated and monitored of refugees’ health status to address their needs per UNHCR policies

Collaborated with ministry of health of Iran to ensure the fulfillment of refugees’ health needs.

Initiated and directed the health activities and collaborated with different national and international counterparts and sponsors to fulfill the refugees' health requirements.

Designed training program vocational skills to empower women refugees.

Negotiated and collaborated with Ministry of Health and Insurance Organization to provide refugees with health insurance.

Facilitated undocumented refugees access to essential primary care and other health services.

Ministry of Health and Medical Education, March 2009 January 2010

Center for Health Education and Health Promotion

Tehran, Iran

Supervisory Senior Expert, Health Education and Health Promotion

Designed national health education strategies and supervised training programs for health experts and the general population. I designed and taught many health topics including:

Mental health awareness

Reproductive health

Communicable disease prevention (primary care prevention and activities to control and manage HIV/AIDS, Tuberculosis, zoonoses disease, …)

Non- communicable disease prevention (primary care activities to control, Diabetes, Hypertension, cancers)

Monitoring and evaluation of health program

Immunization and cold chain management

Health system decentralization definition and methods

Health emergency preparedness and response

Basic Epidemiology and clinical trial design and conduct

Diseases surveillance

Refugees and minorities need.

Social determinants of health

Maternity Leave September 2008- March 2009

World Health Organization (WHO) January 2007 September 2008

Tehran, Iran

Technical Officer, (on Contract per WHO payroll)

Served as the WHO technical officer

Advised and supervised activities by Ministry of Health regarding health system strengthening,

Provided technical support to Ministry of Health to perform health sector reform,

Planned and implemented health program, training activities for health experts on health system strengthening subjects.

. Appraising WHO collaborating centers in Iran and collaborating with EMRO and MOH and with the different national and international donors/counterparts to ensure proper capacity building in health research.

Ministry of Health, January 2006 January 2007

Tehran, Iran

Secretary of Health High Council

I directed the Health High Council’s activities including performing situational analysis, evaluating the national health challenges, drafting and providing high level health information for national decision makers. I have initiated the social determinant of health subjects at the national level, drafted the original national policies and organized the fourth international conference of SDH commissioners in Iran, Jan 2005.

Involved on national strategy development for population health

Advised the high-level health authorities on population health needs

Designed and presented programs for population health improvement to be discussed at policy making meetings by government

Collaborated with WHO to initiate Social Determinant of Health activities within the country

Ministry of Health, Tehran, Iran October 2004 Jan 2006

Senior Expert, Health System Strengthening

I was involved in

Strategic planning for health system performance,

Monitoring and evaluation of primary health care (PHC),

Community health education,

Policy advocacy and negotiation with other stake holders to achieve health system goals including insurance organization, national budget allocating authorities, UN agencies, etc.

Health sector reform and decentralization initiatives

Designing the monitoring and evaluation protocol for provincial health managers.

Establishing a system for family physicians’ performance evaluation.

Co-audited more than 60 facilities and Primary Health Care (PHC)centers annually.

Delivered more than 100 presentations and lectures for health professionals and experts on selected health topics.

Disaster management and providing health services after Bam Earthquake with more than 50,000 casualties.

Developing manuals, guidelines and presentations for health subjects for different levels of audience

Working on partnership building and community outreach.

EDUCATION

Doctor of Medicine, MD September 1991- October 1999

Babol University of Medical Sciences,

School of Medicine, Babol, Iran

CERTIFICATES

1.NVS, Electroencephalography didactic training, in accordance with the standard set forth by the biofeedback Certification International Alliance (BCIA), March 11th, 2016.

2.Health Emergencies in Large Population, John Hopkins University, Bloomberg School of Public Health; July 2010

3.Gender sensitization workshop, arranged by UNFPA, Iran, 27 May 2010

4.Capacity Building Workshop on Health System Development by WHO, Alexandria, Egypt, 2008

5.Health System Decentralization, Nuffield Center for International Health and Development, Leeds University, UK, 2005

6.Decentralization, Sharing Resources and Responsibilities, by The American universities of Beirut, Tehran, 2004

7.Communicable Disease Surveillance and complex emergencies and managing Biological Weapons incidents, by WHO, Tehran, 2003

8.Complex emergency organized by Kurdistan University of Medical Sciences & Medicine de Mond Institute of France, 2003

PUBLICATION

Medical Journal.

•Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomized trials Lancet Oncology, July 2021.

•A Personalized 12-week “Brain Fitness Program” for improving cognitive function and increasing the volume of hippocampus in elderly with mild cognitive impairment, Journal of Prevention of Alzheimer's Disease, 2016

Published Book Chapters:

•Family Physician Performance Monitoring Mehrnoosh Hadadi, Farshad Farzadfar, Jalal Naeli, (ISBN 964-7657-92-7) 2008

•Health System Managers' Performance Monitoring Mehrnoosh Hadadi, Farshad Farzadfar, Davood Moghimi, (ISBN 964-7657-98-6) 2007

•Tools and Techniques for Health Sector Reform (ISBN 964-7657-88-9) 2006

•Referral System and Family Physician Guidelines. (ISBN964-7657-88-9) 2007 Translation

Translation.

•Design and implementation of health information system (by Theo Lippeveld, Rainer Sauerborn, Claude Bodart) Mehrnoosh Hadadi, Farshad Farzadfar, Ghobad Moradi, Farahnaz Farzadfar, ISBN 92 4 1561998. 2006

•Module on Decentralization of Health Systems: Sharing Resources and Responsibilities Thomas J. Bossert, Ph.D. International Health Systems Group, Harvard School of Public Health. Published in Medicine and development magazine. Mehrnoosh Hadadi, Farshad Farzadfar, 2005

REFERENCES

•Dr. Gilbert Burnham,

Professor, John Hopkins School of Public Health,

Department of International Health,

********@*****.***

Tel: 410-***-****

•Dr. Armaghan Emami, Armaghan Emam PharmD, PhD

Pharmacology Toxicology Reviewer

Division of Pharmacology/Toxicology for Neuroscience

Center for Drug Evaluation and Research (CDER)

********.*****@***.***.***

Tel: 410-***-****,

Tel: 301-***-****

•Dr. Shide Badri,

Medical Director, Senior patient safety physician, AstraZeneca

********@*****.***

Tel: 206-***-****

Contact this candidate